Original articleEffects of an Oral Contraceptive (Norgestimate/Ethinyl Estradiol) on Bone Mineral Density in Adolescent Females with Anorexia Nervosa: A Double-Blind, Placebo-Controlled Study
Section snippets
Study population
This study was conducted from September 2002 to April 2004 at 43 investigative sites in the United States. Eligible subjects were adolescent females 11 to 17 years of age with a diagnosis of AN made by the investigator before or at the time of enrollment based on modified DSM-IV guidelines. The modification was in the weight criterion as suggested by Hebebrand et al [23]; the < 85% ideal body weight (IBW) criterion was replaced by an age-adjusted body mass index (BMI) of < 10th percentile [24].
Enrollment and retention of subjects
Of 146 subjects randomized, 23 were screen failures, 123 received at least one dose of study medication (61 NGM/EE; 62 placebo), and 112 had one on-treatment DXA (Figure 1). The majority of discontinuations from treatment were due to “subject choice” (11 NGM/EE; six placebo). Four subjects were withdrawn from the study due to adverse events: three (4.9%) in the NGM/EE group (nausea, weight increase, and menstrual disorder [irregular periods]) and one (1.6%) in the placebo group (headache and
Discussion
After 13 cycles of treatment with a triphasic OC, adolescent females with AN or EDNOS had no statistically significant improvement in LS or hip BMD compared with placebo-treated subjects. A statistically significant increase in LS BMD in OC-treated subjects compared with placebo subjects was observed at the end of six cycles for the total group but the difference did not reach statistical significance for the AN subgroup. Increases in LS and femoral neck BMD were in the 1.5% to 2.5% range after
Acknowledgments
The authors thank the investigators (Paul Ambrosini, M.D.; Louise Beckett, M.D.; Scott Crow, M.D.; Robert Dahmes, M.D.; James Ferguson, M.D.; Ken Fujioka, M.D.; Janet Gersten, M.D.; Peter Gleason, M.D.; Neville Golden, M.D.; Cynthia Guy, M.D.; Katherine Halmi, M.D.; Mazen Hamad, M.D.; Lisa Harris, M.D., Madelon Hartford, M.D.; Craig Johnson, M.D.; James Lee, M.D.; Mark Lerman, M.D.; Michael Levy, M.D.; Robert Littman, M.D.; Stephen Luber, M.D.; Richard Jaffe, M.D.; Madhusmita Misra, M.D.;
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